In its latest licensing deal, BioLineRx Ltd. gained rights to a genetically-engineered version of the capsid protein VP1, a compound believed to have potential in protecting cells following acute kidney injury.

The company entered a worldwide agreement with Gene Vector Technologies Ltd., of Israel, to develop and commercialize BL-4040, a non-viral agent derived from the outer shell of the virus SV40. Initially invented by Ariella Oppenheim and Yosef Haviv, both of Hadassah University Hospital in Jerusalem, BL-4040 aims at preventing apoptosis in kidney cells following acute kidney injury (AKI) by boosting the natural stress response and survival pathways. In preclinical studies, the compound demonstrated an ability to protect cultured cells from apoptosis in vitro and to increase survival when AKI was induced in mice.

According to BioLineRx, anywhere from five percent of 15 percent of hospitalizations are complicated by AKI, which can lead to end-stage renal failure. Though there are several potential causes, such as sepsis and ischemia, BioLineRx intends first to pursue AKI caused by exposure to nephrotoxic agents, namely contrast media.

The use of dyes in CT scans are especially harmful to elderly patients, said Morris Laster, CEO of the Jerusalem-based firm, and that often "limits the ability of physicians to diagnose and treat the disease" in those patients. It's a "tremendously underserved market," he added.

The company intends to start with feasibility studies "to see if it protects kidney cells," and, "if that's successful, we'll go into full preclinical development" and then move into the clinic, Laster told BioWorld Today. Feasibility studies generally take about six to nine months.

That's the way BioLineRx has operated since its founding in 2003. The firm is set up to in-license a number of early-stage programs - it expects to add as many as five or six compounds to its pipeline each year, Laster said - with the goal of moving them quickly through a rigorous screening process to determine which are worthy of further development. Already, the company has discarded a handful of programs, even as it continues to build its portfolio. Only last month, BioLineRx added BL-4030, a small molecule for cancer, licensed from the University of Illinois at Champaign-Urbana, and, in March, the firm in-licensed three therapeutic candidates: BL-3040, a small molecule for estrogen-related malignancies and osteoporosis; BL-3050, a protein complex for atherosclerosis; and BL-4020, a peptide for inflammatory diseases.

The company's most advanced program, BL-1020 has moved into Phase IIa testing. That product, an oral, GABA-enhanced, antipsychotic candidate for schizophrenia, has so far shown promise in blocking dopamine receptors in the brain. Results of the Phase II study are expected in the fourth quarter. Including BL-1020 and the recently licensed BL-4040, BioLineRx has a total of 14 compounds in the pipeline, Laster said.

"One of those is about to enter pilot studies," he said, referring to BL-1040, an absorbable implant to treat cardiac tissue damaged by acute myocardial infarction. The company submitted a request to European regulators in June for Phase I/II studies of that product in Europe and Israel. "And three more [are expected to be] in the clinic in 2008."

The company's pipeline targets multiple disease areas, such as oncology, infectious and inflammatory disease, central nervous system disease and cardiovascular and metabolic disorders.

BioLineRx went public earlier this year, raising $50 million and gaining a listing on the Tel Aviv Stock Exchange. Shares (TASE:BLXR) closed Monday at NIS4.55 (US$1.10) up NIS0.19.

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